Stefanie Hoff

Lead: Deviation- & CAPA Management Implementation & Execution for upstream manufacturing (incl. investigations, change controls & plant exceptions) Responsibilities: Deputy of section manager; SME for manufacturing equipment & processes; Ensuring daily manufacturing activities, like scheduling, recipe, validation, tech transfers, GMP readiness & trainings; Participation in cross functional projects related to continues process improvements

Leading 44 employees. Deputy of associate director; Manufacturing area manager on the floor; Management & Coordination of all upstream manufacturing projects, commissioning- & validation activities in compliance with cGMP, EHS & Quality policies; Ensuring operational readiness & successful engineering run in close collaboration with other stake holders; Leading cross-functional trouble shooting-, improvement- & inspection readiness projects; Supervision of manufacturing staff

Leading 14 employees. Deputy head of process maintenance; Management of process maintenance activities & performances (incl. Planning & Scheduling of Resources & Spare Parts), trouble shootings, technical RCA´s, deviations, change controls, improvement- & CAPA projects, PRCDs & work instructions in compliance with Quality, EHS & cGMP; Ensuring manufacturing upstream equipment’s availability & production efficiency; Representative in audits; Trainer for technicians & manufacturing associates

Management of process equipment’s´ from commissioning, engineering run to manufacturing batches; Managing of daily pre-work activities & shift organization of technicians, including work permits, Loto plans, work documentation & review in compliance with EHS, Quality & cGMP; Collaboration & coordination with subcontractors & stake holders like planning & scheduling, engineering & manufacturing; Leading trouble shootings, technical issue analysis & improvement projects to increase asset utilization

Responsibilities: Process- & plant safety of pharmaceutical production plants; Reporting & adherence project KPIs to plant manager; Coordination & lead of SME’s & plant engineers in process- (HAZOP), machinery- & risk assessments; Implementation of protection concepts, permit-, change- & licensing procedures; Training of professionals

Lead & execution of machinery safety assessments; Design & Implementation of new digital strategies & standards, such as data modeling & digitization of work processes; Development of a new digital data- & interface management system that bundles & evaluates various interdisciplinary fields of activities, enabling efficient resource planning (availability acquisition of SME’s, requirement assessment of different sites & coordination of responsibilities); Process hazard risk assessments; PHA qualification

Responsibilities: Pharmaceutical plant planning and construction projects, from basic engineering to commissioning; Coordination with other departments, contractors & suppliers; Installation supervision; quality-, material- & schedule management; Implementation of Smart3D software (industry 4.0); Cost estimation; QA/QC of planning- & construction companies; Progress tracking; Forecast & work packages assignments, Spare part supplier management

Responsibilities: Specification, 3D planning & procurement of pipes, fittings & spare parts, ensuring compliance with quality standards; Scope changes- & GCC management; Interface management for construction-, assembly- & planning companies; PID-, isometric control; Progress tracking; Forecast & assigning work packages; Ensuring timelines & scopes for FAT, SAT & mechanical completion

Responsibilities: Interface coordination for construction management, Planning- & Assembly companies; Support in material & spare part specification & procurement; PID- & isometry control; Project documentation & Change Control

Vorlesungs- und Praktikumsbetreuung

Erstellung von Apparatebauübungen für die Bachelorvorlesung

Betreuung der Praktika

Entwicklung einer Anlage zur Herstellung von PVC Organosolen

"Vergleich des Partikeldesigns von auf einem Pelletierteller und in einem Intensivmischer erzeugten Agglomeraten"

" Vakuumstandardisierung in einer chemischen Produktionsanalge".

Laborassistentin und Praktikumsbetreuung